A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rigid Plate Fixation
- Sponsor
- Zimmer Biomet
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of sternal wound infection
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
Detailed Description
The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary. The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \& SSWI) at 30 days post-op. The secondary endpoints of evaluation up to 60-days post-operative are defined by: * Quality of recovery after surgery (QoR-15) * Days alive out of the hospital and at home (DAH) * Disability-free survival (WHODAS 2.0.) * Pain scores: Likert scale 1-10 * Opioid pain medication usage * Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female
- •≥ 18 years of age, no upper limit
- •Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System
- •Willing to sign Informed Consent prior to the cardiac surgical procedure
- •Willing and able to provide follow-up information up to 60-days post-operative
Exclusion Criteria
- •Inclusion Criteria
- •Male and female
- •≥ 18 years of age, no upper limit
- •Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System
- •Willing to sign Informed Consent prior to the cardiac surgical procedure
- •Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria
- •Pre-operative
- •Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- •Active or latent infection (with positive culture)
- •Documented foreign body sensitivity, allergy, or intolerance to metals.
Outcomes
Primary Outcomes
Incidence of sternal wound infection
Time Frame: 30 days
Rate of deep sternal wound infection and superficial sternal wound infection
Secondary Outcomes
- Days alive and out of the hospital(60 days)
- Quality of recovery after surgery(60 days)
- Pain score(60 days)
- Opioid medication usage(60 days)
- Inspirometry vital capacity(60 days)
- Disability-free survival(60 days)